A Phase 1b/2 Study of Sonrotoclax (BGB-11417) as Monotherapy and in Various Combinations With Dexamethasone Plus Carfilzomib, Dexamethasone Plus Daratumumab, and Dexamethasone Plus Pomalidomide in Multiple Myeloma
NCT ID: NCT04973605
Last Updated: 2025-11-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1/PHASE2
246 participants
INTERVENTIONAL
2021-09-16
2026-11-30
Brief Summary
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The study investigates sonrotoclax alone and in combination with dexamethasone and other agents, including carfilzomib, daratumumab, and pomalidomide.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Part 1 Dose Escalation
Dose-escalation and de-escalation to determine maximum tolerated dose (MTD) of sonrotoclax plus dexamethasone, sonrotoclax plus dexamethasone plus carfilzomib, sonrotoclax plus dexamethasone plus daratumumab, and sonrotoclax plus dexamethasone plus pomalidomide.
Sonrotoclax
Administered orally daily
Dexamethasone
Once weekly either orally or intravenously
Carfilzomib
Administered intravenously weekly
Daratumumab
Administered subcutaneously weekly
Pomalidomide
Administered orally daily
Part 2 Cohort Expansion
There will be up to 7 expansion cohorts to further evaluate the safety and efficacy of sonrotoclax monotherapy, sonrotoclax plus dexamethasone in combination with dexamethasone plus carfilzomib, and in combination with dexamethasone plus daratumumab
Sonrotoclax
Administered orally daily
Dexamethasone
Once weekly either orally or intravenously
Carfilzomib
Administered intravenously weekly
Interventions
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Sonrotoclax
Administered orally daily
Dexamethasone
Once weekly either orally or intravenously
Carfilzomib
Administered intravenously weekly
Daratumumab
Administered subcutaneously weekly
Pomalidomide
Administered orally daily
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. A confirmed diagnosis of multiple myeloma (must have an M-component in serum and/or urine)
3. Measurable disease defined as:
i. M-spike ≥ 500mg/dL, or ii. Urine protein M-spike of ≥ 200 mg/day, or iii. Serum free light chains ≥ 10 mg/dL, and an abnormal κ:λ ratio
4. Participant has documented relapsed or progressive MM on or after any regimen or who are refractory to the most recent line of therapy.
i. Relapsed MM is defined as previously treated MM that progresses and requires initiation of salvage therapy but does not meet the criteria for refractory MM.
ii. Refractory MM is defined as disease that is nonresponsive (failure to achieve minimal response or development of progressive disease) while on primary or salvage therapy or progresses within 60 days of last therapy.
1. In Part 1 and Part 2 Cohorts 1 and 2 participants should have relapsed or progressive disease and have had ≥ 3 prior lines of therapy including a proteasome inhibitor, an IMiD, and an anti-CD38 monoclonal antibody, and no more available approved therapies.
2. Participants in Part 2 Cohorts 3, 4, and 5 should have relapsed or progressive disease and have had ≥ 1 prior line of therapy. Prior treatment with carfilzomib is allowed but the patient must not be considered carfilzomib refractory by the investigator.
3. Participants in Part 2 Cohorts 6 and 7 should have relapsed or progressive disease and have had 1 to 3 prior lines of therapy and previously treated with a proteasome inhibitor and an IMiD
5. Positivity for t(11;14) translocation must be confirmed by validated fluorescence in situ hybridization (FISH) testing assay in a pre-defined laboratory
a. fresh bone marrow aspirate sample must be collected at screening and sent to central laboratory for t(11;14) FISH testing.
6. Adequate organ function defined as:
1. Hemoglobin ≥ 8.0 g/dL within 7 days before first dose of study treatment, (transfusions, in accordance with institutional guidelines, are permitted)
2. Platelet count ≥ 75,000/μL, within 7 days before first dose of study treatment, independent of growth factor support and transfusions
3. Absolute neutrophil count (ANC) ≥ 1000/mm\^3 within 7 days before first dose of study treatment
4. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 x upper limit of normal (ULN) and total bilirubin ≤ 2.0 x ULN N (total bilirubin must be \< 3 x ULN for patients with Gilbert's syndrome)
Exclusion Criteria
1. Non secretory MM (Serum free light chains \< 10 mg/dL)
2. Solitary plasmacytoma
3. Active plasma cell leukemia (ie, either 20% of peripheral white blood cells or \> 2.0 x 109/L circulating plasma cells by standard differential)
4. Waldenström macroglobulinemia (WM)
5. Amyloidosis.
6. Polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, skin changes (POEMS) syndrome
7. Chronic respiratory disease that requires continuous oxygen
2. Significant cardiovascular disease, including but not limited to:
1. Myocardial infarction ≤ 6 months before screening
2. Ejection fraction ≤ 50%
3. Unstable angina≤ 3 months before screening
4. New York Heart Association Class III or IV congestive heart failure
5. History of clinically significant arrhythmias (eg, sustained ventricular tachycardia, ventricular fibrillation, or torsades de pointes)
6. Heart rate-corrected QT interval \> 480 milliseconds based on Fridericia's formula
7. History of Mobitz II second-degree or third-degree heart block without a permanent pacemaker in place
8. Uncontrolled hypertension at screening, defined as systolic blood pressure \> 170 mmHg and diastolic blood pressure \> 105 mmHg by ≥ 2 consecutive measurements. Prior therapy with sonrotoclax or other agents inhibiting BCL2 activity (eg, venetoclax)
3. Known infection with human immunodeficiency virus (HIV)
4. Serologic status reflecting active viral hepatitis B (HBV) or viral hepatitis C (HCV) infection as follows:
1. Presence of hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb). Participants with presence of HBcAb, but absence of HBsAg, are eligible if HBV DNA is undetectable (limitation of sensitivity \< 20 IU/mL) ,), and if they are willing to undergo monthly monitoring for HBV reactivation.
2. Presence of HCV antibody. Participants with presence of HCV antibody are eligible if HCV RNA is undetectable (limitation of sensitivity \< 15 IU/mL).
18 Years
ALL
No
Sponsors
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BeOne Medicines
INDUSTRY
Responsible Party
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Locations
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University of Alabama At Birmingham Hospital
Birmingham, Alabama, United States
City of Hope National Medical Center
Duarte, California, United States
City of Hope At Irvine Lennar
Irvine, California, United States
University of California At San Francisco
San Francisco, California, United States
University of Miami
Miami, Florida, United States
Emory University Winship Cancer Center
Atlanta, Georgia, United States
University of Chicago Medical Center
Chicago, Illinois, United States
Southern Illinois University School of Medicine
Springfield, Illinois, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Washington University School of Medicine
St Louis, Missouri, United States
Hackensack University Medical Center
Hackensack, New Jersey, United States
Weill Cornell Medical College Newyork Presbyterian Hospital
New York, New York, United States
Memorial Sloan Kettering Cancer Center Mskcc
New York, New York, United States
The James Cancer Hospital and Solove Research Institute At Ohio State University
Columbus, Ohio, United States
Huntsman Cancer Institute
Salt Lake City, Utah, United States
University of Washington
Seattle, Washington, United States
University of Wisconsin Carbone Cancer Center
Madison, Wisconsin, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Canberra Hospital
Garran, Australian Capital Territory, Australia
Nepean Hospital
Kingswood, New South Wales, Australia
Monash Health
Clayton, Victoria, Australia
St Vincents Hospital Melbourne
Fitzroy, Victoria, Australia
The Alfred Hospital
Melbourne, Victoria, Australia
Royal Perth Hospital
Perth, Western Australia, Australia
Hospital Sirio Libanes Brasilia
Brasília, , Brazil
Instituto Dor de Pesquisa E Ensino Distrito Federal
Brasília, , Brazil
Centro Gaucho Integrado de Oncologia Hospital Mae de Deus
Porto Alegre, , Brazil
Hospital Sao Rafael (Rede Dor)
Salvador, , Brazil
Hospital Sirio Libanes
São Paulo, , Brazil
Hospital Nove de Julho Dasa
São Paulo, , Brazil
Accamargo Cancer Center
São Paulo, , Brazil
Instituto Dor de Pesquisa E Ensino Sao Paulo
São Paulo, , Brazil
Clinica Sao Germano
São Paulo, , Brazil
Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein
São Paulo, , Brazil
Cross Cancer Institute
Edmonton, Alberta, Canada
British Columbia Cancer Agency the Vancouver Centre
Vancouver, British Columbia, Canada
Princess Margaret Cancer Centre
Toronto, Ontario, Canada
Peking University Third Hospital
Beijing, Beijing Municipality, China
Beijing Chao Yang Hospital
Beijing, Beijing Municipality, China
Peking University Peoples Hospital
Beijing, Beijing Municipality, China
Chongqing Cancer Hospital
Chongqing, Chongqing Municipality, China
Fujian Medical University Union Hospital
Fuzhou, Fujian, China
The First Affiliated Hospital of Xiamen University
Xiamen, Fujian, China
Sun Yat Sen University Cancer Center
Guangzhou, Guangdong, China
The Second Hospital of Hebei Medical University
Shijiazhuang, Hebei, China
Henan Cancer Hospital
Zhengzhou, Henan, China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
Union Hospital of Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China
Tongji Hospital of Tongji Medical College Huazhong University of Science and Technology
Wuhan, Hubei, China
Hunan Cancer Hospital
Changsha, Hunan, China
Nanjing Drum Tower Hospital,the Affiliated Hospital of Nanjing University Medical School
Nanjing, Jiangsu, China
Jiangsu Province Hospital
Nanjing, Jiangsu, China
The First Affiliated Hospital of Nanchang University Branch Xianghu
Nanchang, Jiangxi, China
The First Hospital of China Medical University
Shenyang, Liaoning, China
Qingdao Municipal Hospital
Qingdao, Shandong, China
Affiliated Zhongshan Hospital of Fudan University
Shanghai, Shanghai Municipality, China
Shanghai Fourth Peoples Hospital Affiliated to Tongji University
Shanghai, Shanghai Municipality, China
Tianjin Medical University General Hospital
Tianjin, Tianjin Municipality, China
Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciencestuanbo Branch
Tianjin, Tianjin Municipality, China
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Universitaetsklinikum Aachen
Aachen, , Germany
Universitatsklinikum Carl Gustav Carus An Der Technischen Universitat Dresden
Dresden, , Germany
Universitatsklinikum Hamburg Eppendorf
Hamburg, , Germany
Universitatsklinikum Wurzburg
Würzburg, , Germany
University Hospital of Alexandroupolis
Alexandroupoli, , Greece
General Hospital of Athens Alexandra
Athens, , Greece
Rabin Medical Center
Petah Tikva, , Israel
Sourasky Medical Center
Tel Aviv, , Israel
Azienda Ospedaliera Policlinico Di Bari
Bari, , Italy
Policlinico Sorsola Malpighi, Aou Di Bologna
Bologna, , Italy
Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori Irst
Meldola, , Italy
Istituto Europeo Di Oncologia
Milan, , Italy
Istituto Di Candiolo Irccs
Torino, , Italy
Azienda Ospedaliera Universitaria Delle Marche
Torrette, , Italy
National University Hospital Singapore
Singapore, , Singapore
Samsung Medical Center
GangnamGu, Seoul Teugbyeolsi, South Korea
The Catholic University of Korea, Seoul St Marys Hospital
SeochoGu, Seoul Teugbyeolsi, South Korea
Severance Hospital Yonsei University Health System
SeodaemunGu, Seoul Teugbyeolsi, South Korea
Seoul National University Hospital
Seoul, Seoul Teugbyeolsi, South Korea
Asan Medical Center
SongpaGu, Seoul Teugbyeolsi, South Korea
Hospital Clinic de Barcelona
Barcelona, , Spain
Hospital San Pedro de Alcantara
Cáceres, , Spain
Hospital Universitario Virgen de La Victoria
Málaga, , Spain
Hospital Universitario Virgen Del Rocio
Seville, , Spain
Churchill Hospital Oxford University Hospital Nhs Trust
Headington, , United Kingdom
University College Hospital
London, , United Kingdom
Royal Marsden Nhs Foundation Royal Marsden Hospital
Sutton, , United Kingdom
Royal Cornwall Hospitalsnhs Trust
Truro, , United Kingdom
Countries
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Central Contacts
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Other Identifiers
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2023-507751-30-00
Identifier Type: CTIS
Identifier Source: secondary_id
2021-003614-39
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
U1111-1277-5444
Identifier Type: OTHER
Identifier Source: secondary_id
CTR20231932
Identifier Type: OTHER
Identifier Source: secondary_id
BGB-11417-105
Identifier Type: -
Identifier Source: org_study_id